Masimo Radius VSM AFib detection gains FDA clearance
The FDA has cleared AFib detection on Masimo’s Radius VSM wearable monitor, following its June 2026 clearance for opioid induced respiratory depression. Medigear.uk covers the clearance and the market context.
The Food and Drug Administration (FDA) has cleared Masimo Radius VSM AFib detection. The feature adds atrial fibrillation (AFib) analysis to Masimo's wearable vital signs monitor, now a Danaher subsidiary. The clearance moves Radius VSM past single readings. It now supports earlier checks of irregular heart rhythms.
How the feature works
The function, photoplethysmography (PPG) AFib, continuously analyses pulse waveform data from the Radius VSM. It uses pattern recognition and AI-based signal analysis of light-based optical sensing. Masimo's smartSET pulse oximetry sensor platform powers it. It helps clinicians decide when patients with irregular rhythms need an ECG or telemetry check.
A second clearance and the executive view
The FDA cleared opioid induced respiratory depression (OIRD) detection on the same device in June 2026. PPG AFib follows that clearance.
Masimo president Tim Benner said smartSET brings intelligent sensing and AI enabled detection to the bedside. He said: "For more than three decades, Masimo has expanded what clinicians can expect from pulse oximetry." He added: "Looking ahead, we intend to continue expanding the smartSET platform to address other critical clinical needs."
Market position
A GlobalData market model puts Masimo at 21.3% of the global pulse oximeter market in 2025. Its US share was 23.1%. The global pulse oximetry systems market measures blood oxygen saturation and heart rate. GlobalData forecasts yearly growth (CAGR) of about 4.2%, with the market reaching around $2.2bn by 2035.
Ownership and legal background
Danaher bought Masimo for $9.9bn in June. The deal, announced in February, aims to strengthen Danaher's acute-care offering. Danaher CEO Rainer Blair said then that it would "greatly strengthen" the diagnostics franchise.
The sale closed a hard chapter for Masimo. The company had fought Apple over blood oxygen meters, claiming Apple copied methods for measuring biomarkers with light sensors. In November 2025, a California court awarded Masimo $634m in damages from Apple over patent infringement.
Why AFib matters
AFib is found in over 10% of patients older than 65. Untreated, it can cause stroke and heart failure. Pulsed field ablation (PFA) has widened treatment options. It is a catheter-based method that uses high-energy electrical pulses to destroy abnormal heart tissue.
Boston Scientific, Medtronic and Johnson & Johnson (J&J) were early movers. GlobalData forecasts a CAGR of about 16.9% for PFA, with the market reaching $16.4bn by 2035.
Why it matters
Masimo Radius VSM AFib detection gives clinicians a screening cue on a device already used for vital signs. Medigear.uk follows Masimo Radius VSM AFib detection and wider patient monitoring news.
Source: Medical Device Network
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